BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SS WHITE CARBIDE BUR

    MDR report key: 23881355 · Received December 23, 2025

    Report

    Report Number
    2245654-2025-00015
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 23, 2025
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, AN INVESTIGATION WAS PERFORMED ON PARTS OF THE SAME MODEL AND CATALOG NUMBER. NECK STRENGTH TESTING ON THE 20-PIECE SAMPLE WAS PERFORMED PER ISO 3823-1. ALL 20 SAMPLES PASSED THE NECK STRENGTH VERIFICATION TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, THE BUR BROKE WHILE DRILLING OUT SOME TOOTH DECAY. ALTHOUGH A PATIENT WAS REPORTEDLY INVOLVED, IT IS UNKNOWN WHETHER PATIENT WAS INJURED AND/OR THE EXTENT OF INJURIES. SS WHITE BURS RECEIVED A TOTAL FOUR MEDWATCH REPORTS ON (B)(6) 2025 FROM THE FDA CONTAINING IDENTICAL INFORMATION AND DESCRIBING THE SAME EVENT AS REPORTED HEREIN. THEREFORE, A SINGLE MDR IS BEING SUBMITTED TO REPRESENT ALL FOUR MEDWATCH REPORTS. THE FOUR MEDWATCH REPORTS ARE: MW5178426, MW5178425, MW5178427 AND MW5178428. SS WHITE HAS BEEN UNABLE TO VERIFY WITH THE CUSTOMER THAT MORE THAN ONE EVENT OCCURRED. IF CONFIRMATION OF ADDITIONAL EVENTS IS RECEIVED, A SUBSEQUENT MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058496 SS WHITE CARBIDE BUR DENTAL BUR EJL SS WHITE BURS LLC FG-330 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other